Marketing authorisation holders are encouraged, where possible or where considered necessary by the competent authority, to test additional risk minimisation materials with patients and/or healthcare professionals.
Where the RMP requires user/readability testing (user testing), a declaration should be provided, together with a proposal for how the testing is to be conducted. It is recommended, where possible, that testing be performed using already approved or revised materials.
Such user testing should assess the suitability of the materials, for example with regard to the environment and circumstances of the target populations; their comprehensibility and usability, including whether different patients and/or healthcare professionals correctly understand the risk-related information and are able to identify the additional risk minimisation measures; and their user-friendliness, for example in terms of colours, font type and size, typography, layout, bullet points, summaries and tables of contents in the case of longer risk minimisation materials.
Any communication with patients or healthcare professionals in this context must be strictly non-promotional and must not contain any promotional elements.
The purpose of user testing is to ensure that the materials are genuinely effective, understandable and usable in real-life settings.
